国产18甲基炔诺酮皮下埋植剂和Norplant的临床比较性研究——666例4年报告

Comparative Clinical Study of Sino-implant -a Levonorgestrel Subdermal Implant -and Norplant 4 Years Report 666 cases

本文旨在研究国产18甲基炔诺酮皮下埋植剂避孕的有效性及其副反应,与Norplant作比较.666例对象经过4年观察.国产组共发生4例妊娠,4年累积妊娠率为1.07/100妇女,年平均妊娠率为0.27/100妇女,4年累积的续用率为76.6/100妇女.与国外Nor-Plant组相比较,都无统计学差异.两组副反应亦相似,主要均为月经失调,占终止者的半数以上.国产组的左旋18甲基炔诺酮的血药水平下降得较快,2年以后略低于Norplant组,但到48个月时仍在抑制排卵的血药水平.4年临床观察国产组与Norplant相似,都具有长效、高效、可逆、稳定的优点,是可供育龄妇女选用的新避孕法.

Purpose to study effectiveness and side effects of the Sino - implant梐 levonorgestrel sub-dermal implant. Methods:The present study is a prospective randomized multicentre with clinical trial of the Sino -implant,?a subdermal implant beginning in 1991 where 666 healthy women under 40 years of age were recruited. Half of them used Sino - implant (made in Shanghai .China). This contraceptive implant is comprised of 2 silicon rods,each having 75 mg levonorgestrel. the other half used Norplant (Made in Leiras. Finland). Both groups were followed up for 4 years. Serum levonorgestrel was measured every year. Results :In Sino - implant group 4 year cumulative pregnancy rate was 1. 07/100 women,mean 0. 27/100 women/year. 4 years cumulative continua-tion rate was 76. 6/100 women. The Norplant group showed no significant difference. The main side effect of the 2 groups was menstrual disturbance. This accounted for more than half of those terminating the use. Serum levonorgestrel level of Sino -implant declined faster, and its level dropped lower than LNG levels of Norplant after 24th month. Howerer , serum level of Sino - implant was still within non - ovulation level in 48th months. Conclusions : The Sino - implant similar to the Norplant is an effective , long - term, reversible and safe contraceptive method for reproductive women.